Brand Story
19 May 2023, 22:45 GMT+10
STEMart, a US-based provider of comprehensive services for all phases of medical device development, is pleased to announce that it offers Disinfection Validation Services for reusable medical devices. These services are designed to ensure that products meet FDA requirements for disinfection validation and patient safety.
Cleaning validation services must be performed on reusable instruments, trays, surgical kits, and similar items that have been used in patient care. Therefore, manufacturers of reusable medical devices must provide reprocessing instructions describing cleaning, disinfection and sterilization and prove that these procedures are effective.
Medical Device Disinfection Validation is used to verify the manufacturer's description of the disinfection steps to demonstrate the effectiveness of the microbicidal process. Disinfection validation studies should focus on 'worst case' scenarios to show that end users can reliably disinfect devices when instructions are followed.
STEMart now offers Disinfection Validation Services for reusable medical devices to ensure customer products meet FDA's disinfection validation requirements and patient safety. The validation processes are in compliance with AAMI TIR12, ANSI/AAMI ST58, ISO 15883 series, ISO 17664, and FDA guidance documents. In addition to helping customers validate specific processes, STEMart also provides guidance on protocols for designing and manufacturing reusable devices.
STEMart now offers Disinfection Validation Services for reusable medical devices to ensure that customer products meet FDA requirements for disinfection validation and patient safety. These validation processes comply with AAMI TIR12, ANSI/AAMI ST58, ISO 15883 series, ISO 17664 and FDA guidance documents. In addition to helping customers validate specific processes, STEMart also provides guidance on protocols for designing and manufacturing reusable devices.
Disinfection employs physical or chemical methods to kill microorganisms, usually accomplished through chemical disinfectants or thermal disinfection. Validation of chemical disinfection is performed in a variety of ways to support high, intermediate and low level disinfection, depending on the required disinfection leverage. The level of disinfection is determined by the category of the device (critical, semi-critical, or non-critical). These validations require that the device be inoculated with bacteria and then immersed in a liquid chemical disinfectant solution. Finally, any remaining bacteria are extracted from the device and grown on plates in a manner similar to a bioburden test.
The other type of disinfection, thermal disinfection, utilizes hot water from 60C to 95C (140F to 203F). The level of thermal disinfection depends on the contact time and temperature.
If you are looking for professional disinfection validation services for your reusable medical devices, or would like to know more about STEMart's medical device development service, please visit https://www.ste-mart.com/.
About STEMart
STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols in order to access better health worldwide.
Get a daily dose of Albuquerque Express news through our daily email, its complimentary and keeps you fully up to date with world and business news as well.
Publish news of your business, community or sports group, personnel appointments, major event and more by submitting a news release to Albuquerque Express.
More InformationIn the past month alone, 23 Israeli soldiers have been killed in Gaza—three more than the number of remaining living hostages held...
LONDON, U.K.: At least 13 people are believed to have taken their own lives as a result of the U.K.'s Post Office scandal, in which...
WASHINGTON, D.C.: Travelers at U.S. airports will no longer need to remove their shoes during security screenings, Department of Homeland...
WASHINGTON, D.C.: An elaborate impersonation scheme involving artificial intelligence targeted senior U.S. and foreign officials in...
SLUBICE, Poland: Poland reinstated border controls with Germany and Lithuania on July 7, following Germany's earlier reintroduction...
WASHINGTON, D.C.: After months of warnings from former federal officials and weather experts, the deadly flash floods that struck the...
WASHINGTON, D.C.: A federal rule designed to make it easier for Americans to cancel subscriptions has been blocked by a U.S. appeals...
BASTROP, Texas: In a surprising turn at Elon Musk's X platform, CEO Linda Yaccarino announced she is stepping down, just months after...
NEW YORK CITY, New York: Former British prime minister Rishi Sunak will return to Goldman Sachs in an advisory role, the Wall Street...
LONDON, U.K.: Physically backed gold exchange-traded funds recorded their most significant semi-annual inflow since the first half...
AMSTERDAM, Netherlands: Some 32 percent of global semiconductor production could face climate change-related copper supply disruptions...
NEW YORK, New York - U.S. stocks rebounded Tuesday with all the major indices gaining ground. Markets in the UK, Europe and Canada...